FDA

• The FDA issued an updated Emergency Use Authorization (EUA, 12/28/21) permitting the use of high-titer COVID-19 convalescent plasma only for patients who are immunosuppressed or receiving immunosuppressive therapy, whether hospitalized or ambulatory.
• The FDA EUA specifies the following:
  • Only high titer plasma units are authorized for administration. COVID-19 convalescent plasma must be tested for anti-SARS-CoV-2 antibodies with 1 of 6 available kits (See Appendix A in 12/28/21 EUA)
  • The administration should be initiated with 1 unit (200 mL).
    • Additional convalescent plasma units may be administered based on the patient’s clinical response.
  • Physicians should consider using COVID-19 convalescent plasmas among patients with impaired humoral immunity.
  • Healthcare providers must make the FDA Fact Sheet for Patients and Parents/Caregivers available before use.